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Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Sponsor: Laminate Medical Technologies
Summary
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula
Official title: Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-01-13
Completion Date
2028-05
Last Updated
2025-10-30
Healthy Volunteers
No
Conditions
Interventions
VasQ
External support implant for the arteriovenous fistula
Arteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access
Locations (7)
Fresenius Vascular Care Long Beach
Long Beach, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Greenwood Leflore Hospital
Greenwood, Mississippi, United States
Azura Surgery Center Las Vegas
Las Vegas, Nevada, United States
Fresenius Vascular Care Columbia
Columbia, South Carolina, United States
Fairlawn Surgery Center
Roanoke, Virginia, United States